MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA®; SPINAL CORD STIMULATOR

Model Number SC-8216-70

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Weakness (2145); Numbness (2415)

Event Date 04/07/2015

Event Type  Injury  

Event Description

A report was received that the patient was experiencing increased thoracic and neck pain, weakness and numbness in good arm, and neurological deficit.The physician took series of scans and confirmed that the lead had moved down even further to the thoracic spine and that the body of the lead had completely separated from the lead tails in which he could only identify 13 contacts.The contacts had stacked on top of each other and appeared as one contact on imaging.The physician believed that the symptoms were device related due to the lead pulling down from the cervical region to upper thoracic spine.It was also suspected that the cause for neurological symptoms was the actual material of the migrated lead in the low cervical/high thoracic area.The lead had pulled out of the epidural space as confirmed by computerized tomography (ct) scans and x-rays.The patient underwent a revision procedure wherein the lead body and all 16 contacts were removed.The patient was doing well postoperatively and was discharged from the hospital.

Manufacturer Narrative

The explanted body of the lead was not returned to bsn as it was discarded by the medical facility.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.

Event Description

A report was received that the patient was experiencing increased thoracic and neck pain, weakness and numbness in good arm, and neurological deficit.The physician took series of scans and confirmed that the lead had moved down even further to the thoracic spine and that the body of the lead had completely separated from the lead tails in which he could only identify 13 contacts.The contacts had stacked on top of each other and appeared as one contact on imaging.The physician believed that the symptoms were device related due to the lead pulling down from the cervical region to upper thoracic spine.It was also suspected that the cause for neurological symptoms was the actual material of the migrated lead in the low cervical/high thoracic area.The lead had pulled out of the epidural space as confirmed by computerized tomography (ct) scans and x-rays.The patient underwent a revision procedure wherein the lead body and all 16 contacts were removed.The patient was doing well postoperatively and was discharged from the hospital.

Manufacturer Narrative

Additional information was received that the patient will undergo an ipg explant procedure.Additional suspect medical device component involved in the event: model #: sc-1132, serial #: (b)(4), description: precision spectra implantable pulse generator.

Manufacturer Narrative

Additional information was received that there will be no further course of action regarding the ipg explant at this time.

Event Description

A report was received that the patient was experiencing increased thoracic and neck pain, weakness and numbness in good arm, and neurological deficit.The physician took series of scans and confirmed that the lead had moved down even further to the thoracic spine and that the body of the lead had completely separated from the lead tails in which he could only identify 13 contacts.The contacts had stacked on top of each other and appeared as one contact on imaging.The physician believed that the symptoms were device related due to the lead pulling down from the cervical region to upper thoracic spine.It was also suspected that the cause for neurological symptoms was the actual material of the migrated lead in the low cervical/high thoracic area.The lead had pulled out of the epidural space as confirmed by computerized tomography (ct) scans and x-rays.The patient underwent a revision procedure wherein the lead body and all 16 contacts were removed.The patient was doing well postoperatively and was discharged from the hospital.

Manufacturer Narrative

Additional information was received that the patient¿s ipg was explanted to appease the patient.No device malfunction was suspected.The patient was doing well postoperatively.The explanted ipg was not returned to bsn.

Event Description

A report was received that the patient was experiencing increased thoracic and neck pain, weakness and numbness in good arm, and neurological deficit.The physician took series of scans and confirmed that the lead had moved down even further to the thoracic spine and that the body of the lead had completely separated from the lead tails in which he could only identify 13 contacts.The contacts had stacked on top of each other and appeared as one contact on imaging.The physician believed that the symptoms were device related due to the lead pulling down from the cervical region to upper thoracic spine.It was also suspected that the cause for neurological symptoms was the actual material of the migrated lead in the low cervical/high thoracic area.The lead had pulled out of the epidural space as confirmed by computerized tomography (ct) scans and x-rays.The patient underwent a revision procedure wherein the lead body and all 16 contacts were removed.The patient was doing well postoperatively and was discharged from the hospital.

• Brand Name: PRECISION SPECTRA®
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 4734248
• MDR Text Key: 18545819
• Report Number: 3006630150-2015-01056
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2012
• Device Model Number: SC-8216-70
• Other Device ID Number: M365SC8216700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/16/2015
• Initial Date FDA Received: 04/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/26/2015; 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 21 YR