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

Model Number SC-1132

Device Problems Migration or Expulsion of Device (1395); Charging Problem (2892)

Patient Problems Pain (1994); Respiratory Distress (2045)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: sc-2317-70, serial#: (b)(4); description: infinion cx 70 cm lead.

Event Description

A report was received that the patient was experiencing pain in the ribs and was having difficulty breathing due to the charging belt that had to be put on very tightly when charging the ipg.It was noted that the patient was having difficulty charging as the ipg had flipped sideways.The patient will undergo an explant procedure.

Manufacturer Narrative

Additional information was received that no further course of action will be taken at this time.It is indicated that the devices will not be returned for evaluation; therefore a failure of the complaint devices 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 pain in the ribs and was having difficulty breathing due to the charging belt that had to be put on very tightly when charging the ipg.It was noted that the patient was having difficulty charging as the ipg had flipped sideways.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: 7504336
• MDR Text Key: 107921991
• Report Number: 3006630150-2018-01621
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: 08714729821526
• 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
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2018
• Device Model Number: SC-1132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2016
• 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: 42 YR