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

Model Number SC-2218-70

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Impaired Healing (2378)

Event Date 01/05/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-2218-70 serial #: (b)(4) description: linear st lead, 70cm model #: sc-1132 serial #: (b)(4) description: precision spectra implantable pulse generator.

Event Description

A report was received that following the revision procedure (mfr report #: 3006630150-2017-00127), the patient's incisions were not healing well and there was a mild edema at midline incision site.The patient will undergo an explant procedure.

Manufacturer Narrative

Additional information was received that it was believed the known cause of edema came from both surgeries because the patient did not have the leads remove due to any kind of risk of infection.It was noted that the patient's leads kept on migrating and she fell again and the lead moved again.The bsn representative believed that the swelling was due the surgical procedure.

Event Description

A report was received that following the revision procedure (mfr report #: 3006630150-2017-00127), the patient¿s incisions were not healing well and there was a mild edema at midline incision site.The patient will undergo an explant procedure.

Manufacturer Narrative

Additional information was received that there was no medical intervention given for patient's edema in the midline incision from the revision.

Event Description

A report was received that following the revision procedure (mfr report #: 3006630150-2017-00127), the patient¿s incisions were not healing well and there was a mild edema at midline incision site.The patient will undergo an explant procedure.

• 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: 6685172
• MDR Text Key: 79024462
• Report Number: 3006630150-2017-02407
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767749
• UDI-Public: (01)08714729767749(17)160812(10)17186300
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/12/2016
• Device Model Number: SC-2218-70
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2014
• 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): Required Intervention
• Patient Age: 51 YR