MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-1160

Device Problems Power Problem (3010); Wireless Communication Problem (3283)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

Event Type  Injury  

Event Description

It was reported that following a back surgery, the patient could no longer turn the ipg on and was showing a communication failed message as confirmed with the rep.The physician believed that ipg may have been fried with the electrocautery.The patient underwent an ipg replacement procedure and the patient was doing well postoperatively.Electrocautery is a known source of high voltage transient signal and current company labeling warns against the use of electrocautery.(physicians implant manual (b)(4)).

Event Description

It was reported that following a back surgery, the patient could no longer turn the ipg on and was showing a communication failed message as confirmed with the rep.The physician believed that ipg may have been fried with the electrocautery.The patient underwent an ipg replacement procedure and the patient was doing well postoperatively.Electrocautery is a known source of high voltage transient signal and current company labeling warns against the use of electrocautery.(physicians implant manual (b)(4).

Manufacturer Narrative

(b)(6).The returned ipg was analyzed and revealed that the device was undetectable and could not be charged.The battery was replaced by an external power source for further investigation.The patients data would not be retrieved due to the device damage.With all the available information, boston scientific concludes that the complaint was confirmed.The returned ipg was not functional.An internal electrical test revealed excessive current leakage due to asic u2 damage.The patients data would not be retrieved due to the device damage.It appeared that the device was exposed to high voltage transients or high rf (radio frequency) energy.Exposing the ipg to high voltage transients or high rf energy can cause this type of damage.It could not be determined if electrocautery was used during the non-device related surgery.The probable cause selected is unintended use error caused or contributed to event.

• Brand Name: SPECTRA WAVEWRITER
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 11866594
• MDR Text Key: 252048838
• Report Number: 3006630150-2021-02304
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729951254
• UDI-Public: 08714729951254
• Combination Product (y/n): N
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/20/2020
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 342287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR