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

Model Number SC-9218-15

Device Problem Device Stops Intermittently (1599)

Patient Problems Undesired Nerve Stimulation (1980); Discomfort (2330)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model#: sc-9218-15, serial#: (b)(4), description: precision m8 adapter, 15cm.Model#: sc-1132.Serial#: (b)(4), description: precision spectra implantable pulse generator the explanted devices were not returned to bsn.

Event Description

A report was received that the patient was experiencing discomfort.It was noted that the stimulation was shutting on and off periodically even after the reprogramming.The patient underwent a revision procedure wherein the m8 adapters and ipg were replaced.The patient was doing well.

Manufacturer Narrative

Additional information was received that the explanted device was inconsistent in delivering therapy.The physician believed that the coverage/pain relief would be better by replacing the entire system.

Event Description

A report was received that the patient was experiencing discomfort.It was noted that the stimulation was shutting on and off periodically even after the reprogramming.The patient underwent a revision procedure wherein the m8 adapters and ipg were replaced.The patient was doing well.

• 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: 7456207
• MDR Text Key: 106354221
• Report Number: 3006630150-2018-01449
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729888734
• UDI-Public: 08714729888734
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/20/2019
• Device Model Number: SC-9218-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• 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: 72 YR