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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2218-50
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2021
Event Type  malfunction  
Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2218500, model: sc-2218-50, serial: (b)(4), batch: 19013108/19013108.
 
Event Description
It was reported that during an ipg replacement procedure (mfr.Report no.3006630150-2021-02483), the physician was unable to get one of the leads in the new ipg as it had a contact on the end of it that was peeling up.The lead was explanted and the other remaining leads were reimplanted.The patient was doing well postoperatively.
 
Manufacturer Narrative
Sc-2218-50 (sn (b)(6)): the returned lead was analyzed and indicated that the proximal end was deformed and it failed the dimensional test (proximal go/no).The spacer between contact #3 and #4 of the proximal tip has bulged and it resulted in the inability to in and out of the ipg port.The deformation was due to the age of the old lead and it was being reused during the ipg swap.With all the available information, boston scientific concludes that he complaint was confirmed.The proximal array most likely got bent during the procedure.Hence, the probable cause selected for this complaint.
 
Event Description
It was reported that during an ipg replacement procedure (mfr.Report no.3006630150-2021-02483), the physician was unable to get one of the leads in the new ipg as it had a contact on the end of it that was peeling up.The lead was explanted and the other remaining leads were reimplanted.The patient was doing well postoperatively.
 
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Brand Name
LINEAR ST
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 Key11904651
MDR Text Key254279993
Report Number3006630150-2021-02495
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729767725
UDI-Public08714729767725
Combination Product (y/n)N
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/09/2021
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 Date03/14/2018
Device Model NumberSC-2218-50
Device Catalogue NumberSC-2218-50
Device Lot Number19013108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2021
Initial Date Manufacturer Received 05/06/2021
Initial Date FDA Received05/28/2021
Supplement Dates Manufacturer Received06/16/2021
Supplement Dates FDA Received07/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age76 YR
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